Clinical Evaluation (MDD / IVD / AIMD)

Clinical Evaluation according to European Regulation (MEDDEV 2.7.2)

Recent amendments made to the Medical Device Directive (MDD 93/42/EEC) state that every medical device affixing CE Logo, regardless of its classification, must have a clinical evaluation report in its Technical File / Design Dossier.

The Directive specific focus on implantable or class III medical devices gives the false impression that clinical investigation does not apply to other Medical devices. This has lead to the current situation where clinical trials are rarely done in the pre-market steps of development.

Clinical investigation is rarely conducted because of the investment in time, human resources and costs. In addition, clinical investigation is sometimes perceived as risky or harmful. As With the implementation of Directive 2007/47/EC, clinical evaluation has become a central element of regulatory compliance under the Medical Device Directive and Active Implantable Medical Device Directive.

Manufacturers face the greatest impact, as they must present complete and sufficient clinical evaluation files to ensure timely assessment and favorable review of their products.

Benefits of Conducting Clinical Evaluation

Regulatory conformance: Conforming to the regulatory framework is necessary and should be done in order to get Notified Body approval for Technical file followed by CE Certification. Choosing to perform a clinical investigation is the best answer to conform to the new requirements of the Medical Device Directive MDD 93/42/EEC.

Early detection and resolution of safety issues: Over 25% of safety alerts are due to manufacturing defects. This high proportion demonstrates the importance of an early detection of potential safety issues. Early assessment gives the manufacturer time to take corrective action and to provide potential damages to the company reputation.

Manufacturer Image: An early clinical evaluation most often results in a positive image and greater usage of the product throughout the healthcare system. A well-designed clinical investigation based on a robust methodology gives a chance to publish a scientific article in a peer-reviewed journal.

Appoint I 3 CONSULTING for better navigation and ensure timely assessment and favorable review
Our systematic approach includes support in protocol generation, develop fast method to complete clinical evaluation documentation and complete proper conclusion. Our services are online and very economical. We entertain enquiries across the globe.